510(k) K031897 ยท INI Vehicle, Motorized 3-Wheeled
PF-2 BATTERY OPERATED ELECTRIC FOUR WHEEL POWER SCOOTER
| Applicant | Imc-Heart Way LLC, Fort Myers FL, US |
| Decision | Substantially Equivalent, Sep 23, 2003 |
| Received | Jun 19, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K031897
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.